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510(k) K050801

URISCAN OPTIMA II URINE ANALYZER by Yd Diagnostics — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2005
Date Received
March 30, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

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